DIFLUPREDNATE

Product NDC
76282-708
11-digit product format
762820708
Labeler code
76282
Product ID
76282-708_8cddb271-2bf9-4493-b5cf-547f56c46caf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIFLUPREDNATE
Dosage form
EMULSION
Route
OPHTHALMIC
Labeler
Exelan Pharmaceuticals, Inc.
Application
ANDA211776
Marketing category
ANDA
Marketing start
2021-12-10
Marketing end
0000-00-00
Substance
DIFLUPREDNATE
Active strength
1 mg/mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
05bd5167-c8bb-b60b-f647-c2bfd6944eb3Product name520260107
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76282-708-50DIFLUPREDNATE5 mL in 1 BOTTLEEMULSION51
76282-708-50DIFLUPREDNATE1 in 1 CARTONEMULSION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-708-50ML - Milliliter76282-7086c4ce2e6-4b83-478b-a1a5-317e72ffe2c212022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76282-708DIFLUPREDNATE EMULSION [EXELAN PHARMACEUTICALS, INC.]1Legacy NDC, 2 package rows20211212_f7744cc9-bc5b-4642-8b36-07136704910a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
804544difluprednate 0.05 % Ophthalmic EmulsionPSNf7744cc9-bc5b-4642-8b36-07136704910a1
804544difluprednate 0.5 MG/ML Ophthalmic SuspensionSCDf7744cc9-bc5b-4642-8b36-07136704910a1
804544difluprednate 0.05 % Ophthalmic EmulsionSYf7744cc9-bc5b-4642-8b36-07136704910a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76282-708-50762820708501 BOTTLE in 1 CARTON (76282-708-50) > 5 mL in 1 BOTTLE1 bottle2021-12-100000-00-00NoNoCurrent